This Funding Opportunity Announcement (FOA) is to support
the Mental Health Research Network (MHRN), a research resource consortium
within several non-profit integrated health care delivery systems.
Originally, the MHRN was created to develop infrastructure that would
demonstrate the ability to identify, recruit and enroll large patient
populations into effectiveness trials, harmonize electronic medical record
data across multiple integrated systems for research use, pool data for
common analyses, and build capacity for the collection and storage of
biologic material. This FOA is intended to provide targeted expansion of the
network to 1) develop capacity to perform trials involving pharmacotherapy,
2) develop procedures for deploying large-scale mental health IT
interventions, and 3) conduct a signature project of large population impact
on an area of high priority to the field. It is expected that the MHRN will
continue to implement appropriate procedures to collaborate with outside
investigators on a variety of applicable studies, will use the virtual data
warehouse (VDW) on a range of studies including policy impact, practice
variation, and signal detection, and will effectively disseminate the
outcomes of research projects within the large health care delivery systems
to which the MHRN is connected.

Key
Dates

Posted Date

May 8, 2013

Letter of Intent Due Date(s)

June 22, 2013

Application Due Date(s)

July 22, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2013

Advisory Council Review

January 2014

Earliest Start Date

April 1, 2014

Expiration Date

July 23, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS 398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. While
some links are provided, applicants must read and follow all application
instructions in the Application Guide as well as any program-specific instructions
noted in Section IV. When the
program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all
grant programs to electronic submission using the SF424 Research and Related
(R&R) format and is currently investigating solutions that will accommodate
NIH’s multi-project programs. NIH will announce plans to transition the
remaining programs in the NIH
Guide to Grants and Contractsand on NIH’s Applying
Electronically website.

The purpose of this Funding Opportunity Announcement (FOA)
is to support the Mental Health Research Network (MHRN), a research resource
consortium within eleven non-profit integrated health care delivery systems.
This FOA is a limited competition solicitation only open to institutions who
are “members” of the current MHRN consortium funded by an NIMH U19 cooperative
agreement award.

Originally, the MHRN was created to develop infrastructure
that would demonstrate the ability to identify, recruit and enroll large
patient populations into effectiveness trials, harmonize electronic medical
record data across multiple integrated systems for research use, pool data for
common analyses, and build capacity for the collection and storage of biologic
material. Within the initial three-year funding period, the MHRN has
effectively demonstrated each of these capacities through the execution of a
set of infrastructure development projects.

This FOA is intended to provide targeted expansion of the
network through pilot studies and core activities to 1) develop capacity to
perform trials involving pharmacotherapy, 2) develop procedures for deploying
large-scale mental health IT interventions, and 3) conduct a signature project
of large population impact on an area of high priority to the field. It is
expected that the MHRN will continue to implement appropriate procedures to
collaborate with outside investigators on a variety of applicable studies, will
use the virtual data warehouse (VDW) on a range of studies including policy
impact, practice variation, and signal detection, and will effectively
disseminate the outcomes of research projects within the large health care
delivery systems to which the MHRN is connected and beyond.

Need for the Research

Despite the capacity of many health care delivery systems to
provide services to millions of patients with mental disorders, little information
is available on the needs of these populations, the quality of services they
receive, and the extent to which these systems deliver effective interventions.
Furthermore, the cost of conducting large-scale effectiveness trials to answer
important mental health research questions is prohibitive, without taking
advantage of efficiencies within large-scale networks. The clinical
research enterprise, which requires identification of subjects, multiple
strategies for recruitment, enrollment, randomization, data collection, and
ongoing monitoring, limits the number of studies that can be launched anew
within fixed research budgets. The MHRN is intended to address this
limitation.

With significant efforts needed to determine the relative
effectiveness of beneficial treatment, preventive and services interventions
and their capacity for widespread implementation, studies will require large
samples of patients, an abundance of practicing clinicians, integrated data
systems to identify, assess, monitor, and follow-up patients, and capacity to
conduct trials with rapidity, efficiency, safety and quality. The MHRN
will extend upon a platform to conduct a series of effectiveness trials at
costs far below a traditional effectiveness trial.

Background

MHRN
Environment. Currently, the MHRN consists of 11 research sites
at member institutions (research divisions) affiliated with non-profit
integrated health care delivery systems. All these MHRN Member institutions
belong to a consortium of 16 health care delivery organizations with integrated
research divisions, known as the HMO Research Network (HMORN). In addition to
MHRN, HMORN has attracted other NIH-funded research programs including the Cancer Research Network, and the Cardiovascular Research Network, as well as
several programs funded by the Agency for Health care Research and Quality
(AHRQ). The MHRN is thus well positioned to collaborate with experts in other
clinical areas to improve the overall health of people with mental disorders.

The parent HMOs for MHRN Members provide care for
approximately 11 million individuals. These HMOs offer substantial resources
that are potentially useful for the conduct of mental health effectiveness and
services research. These resources include data for: large, well-defined, and
diverse patient populations; long-established administrative and medical
records; physician and patient web portals; biospecimen resources; linkages to
other data systems such as population-based patient registries; and capacity
for rapid identification and accrual of subjects to longitudinal retrospective
and prospective cohorts for observational studies or clinical trials.

Original
MHRN Goals. When the original MHRN FOA was issued, a successful
network was defined as one accomplishing the following tasks:

Demonstrate the ability to identify subjects and determine
“caseness” for inclusion in a prospective study;

Demonstrate the ability to randomize subjects into experimental
and comparison conditions across multiple organizations within the network;

Collect, store, and analyze biologic data for subjects across
multiple organizations within the network;

Launch at least one pilot trial of a mental health intervention
across multiple organizations within the network;

Demonstrate the ability to use IT infrastructure to integrate
research protocols and assessments within typical clinical visits, and pool
data from multiple organizations for analysis.

Existing
MHRN Infrastructure. In response to this set of challenges,
MHRN investigators have completed the following activities:

Enhanced the Virtual Data Warehouse (VDW) to harmonize mental
health diagnosis and treatment data across all sites of the MHRN, establishing
standard definitions for key exposures and mental health outcomes, and
developed procedures for distributing standard programs and aggregating data
across sites.

Conducted observational studies using the VDW to analyze practice
variation across multiple sites, as well as organizing patient-reported outcome
data (PHQ-9 scores) across sites within the MHRN.

Developed and implemented a centralized online platform for
administration of standardized clinical measures across multiple sites, as well
as procedures for online electronic informed consent, protection of personally
identifiable information and transfer of sensitive data. In addition,
procedures have been established for multi-site collection of biological specimens,
including consent, and specimen collection and use. These functions were
created in the context of a patient registry.

Potential
and Need for further improvements. In the initial project
period, the MHRN made substantial progress in demonstrating the viability of
the members to identify, recruit and enroll patients into psychotherapy trials,
in utilizing the VDW to assess practice variation and the impact of policies on
suicidal behavior, in developing patient registries for trials on autism
spectrum disorders, and in enhancing processes for collaboration with outside
investigators. For these tasks, the MHRN no longer requires direct support.
However, NIMH sees key targeted areas in which limited resources may further
enhance the MHRN’s capabilities of efficiently housing a number of high
priority research studies in effectiveness and services research. These areas
include, but are not limited to: 1) developing and testing procedures for
conduct of pharmacotherapy trials within network sites, 2) developing and
testing procedures for trials using technology-driven interventions for prevention,
treatment, or services, and 3) enhancing signal detection of unexpected
positive results from off-label use of therapies. Limited funds are also
available for network oversight and coordination, and for dissemination of
information on the use of MHRN as a platform for the field to conduct
effectiveness and services research.

This FOA is structured around supporting these targeted
activities, through pilot projects, as well as providing funds for a Signature
Project, detailed below, whose findings will have a substantial impact on the
mental health of a large population.

General Requirements

MHRN is expected to continue to function as a resource to
the broad mental health research community mainly through the following
activities:

Maintaining accessibility to relevant data for patient
populations and their providers served by the parent HMOs of MHRN Member
institutions for use by MHRN-affiliated and non-affiliated investigators in
research studies;

Facilitating and coordinating access to these data for research
conducted by MHRN-affiliated and non-affiliated investigators using approaches
and solutions that optimize the use of the MHRN and are conducive to
collaborative efforts;

Maintaining high level of expertise and competency in scientific
areas relevant to MHRN and of potential interest to non-MHRN-affiliated
collaborators;

Sharing this expertise with other (non-MHRN-affiliated) mental
health researchers with the goal to facilitate interactions and research
collaborations among mental health researchers who might benefit from these
data;

Increasing participation of MHRN-affiliated and non-affiliated investigators
in independently funded research relevant to these areas of expertise,
including efforts to increase the number, scope, and scientific impact of
research projects conducted by external investigators in collaboration with
MHRN;

Conduct a Signature Project (described below), a large-scale
pragmatic trial to answer a research question of high impact to improve the
care of people with mental disorders.

Conducting pilot projects (directly funded by MHRN) that will
allow MHRN and external investigators to develop competitive applications for
funding of full research projects. It is expected that by the end of the
proposed MHRN funding period, investigators involved in MHRN-sponsored pilot
projects (including outside collaborators) will have submitted at least 5
investigator-initiated applications for other funding (based on the data from
pilot projects).

Overall
structure of the Network

To ensure efficient conduct of the activities outlined
above, the proposed MHRN structure will be encompassed within the
Administrative Core, and is encouraged to include the following organizational
and functional units, as well as any other units or working groups key to
achieving the aims of the MHRN:

Organizational
Unit must be established to coordinate MHRN administrative
functions, including but not limited to mediating and coordinating
administratively interactions among MHRN Members and providing organizational
support for joint Network activities (e.g., organizing meetings,
teleconferences, etc.).

InformaticsUnit is
the key component for the MHRN resource function. This Unit should be organized
to support MHRN informatics infrastructure, notably including the VDW, and to
continue improvements in data development, informatics tools, etc. The Informatics
Unit should coordinate informatics-related efforts at individual MHRN Member
sites as well as interact with other Units and Projects (see below) to support
their functions.

Outreach
and External Collaboration Unit should work to increase the
usage of the MHRN by external investigators, as well as to support the
implementation of MHRN findings within the partnering health systems. This Unit
is expected to take actions popularizing MHRN as a resource and facilitate
access to external, non-MHRN-affiliated investigators. Importantly, this Unit must
provide a liaison function to help connect non-MHRN-affiliated investigators
with those MHRN investigators who would be most appropriate as experts and/or
potential collaborators. This Unit must also establish an efficient system and
operating procedures for (1) receiving and managing an influx of requests for
access to data, ideas for collaborations, and applications for research
projects from the scientific community and channeling them to relevant MHRN components
or researchers, as well as (2) developing procedures for supporting training
experiences for junior investigators interested in conducting research within
MHRN sites. Finally, this Unit must develop procedures to improve the
connectivity of MHRN findings to member and external health system operations,
both in identifying new research topics for study and to foster population
impact of scientific findings.

Signature
Project

The Signature Project should target a significant problem in
the prevention, treatment, and/or management of a large population of people
with mental disorders served by the health systems affiliated with the
network. It should be designed as a pragmatic trial, meeting the following
criteria:

The pragmatic trial should test an intervention, or compare
several interventions (which can be treatments, preventive actions, policies or
organizational changes) that are robust, apply broadly to patient populations
and are suitable for use in multiple health systems, with the broad goal of
determining whether the intervention improves health and adds value to the
utilization of the nation’s health care resources.

The question should be of major importance to the health of
people with mental disorders—and in which tested interventions are hypothesized
to result in dramatic functional and/or systemic improvements in the health of
the population and the care that they receive.

The intervention(s) should be able to be reliably delivered by
clinical providers typically found in the health care setting and/or health
care systems or self-administered through computer-based technology with
appropriate assessments of quality.

The intervention(s) should be reasonably simple, easily
incorporated into the care setting and not

require a complex structure for
implementation or monitoring.

The trial should exploit opportunities made available by the
nature of the MHRN; for example, the use of primary endpoint events can be
easily captured by passive follow-up, such as electronic health records, or
efficient active data collection, and, ideally, objectively quantified (e.g.
hospitalization, sick days). Furthermore, the costs of conducting the trial
should be a fraction of the historic costs of completing similar trials.

The trial design should incorporate rigorous and robust
comparison conditions, prospectively identified, and feasible to be implemented
within health care systems. The design may incorporate novel randomization
approaches, such as by cluster or timing of implementation. The design should
also maximize external validity of the study, by testing generalizability of
findings across distinct health care settings, and diverse staff and patient
populations.

The trial should enroll hundreds of patients based on broad
eligibility criteria to maximize diversity, with minimum exclusions on risk,
age, health literacy, comorbidities, or expected adherence.

As in routine practice, the pragmatic trial should allow for interventions
to be implemented with maximal flexibility and by all appropriate practitioners
(not just those with exceptional levels of training or competence).

Example
Topics for Signature Project Consideration

Below are example topics of high impact for consideration as
a theme for the Signature Project. Each example is intended to define an
opportunity to make significant improvements on the outcomes of large
populations served by the MHRN. The list below is intended to be suggestive,
not exhaustive; other research areas of equivalent or higher impact should be
considered.

Data suggest the high use of antipsychotic treatments for
non-psychotic conditions in children and adolescents. The resulting risk of
metabolic adverse effects is unnaturally high, and has severe impacts on the
healthy development and well-being of thousands. Approaches to reduce the use
of antipsychotics in child and adolescent populations could dramatically
improve health and mental health outcomes across the country.

People with severe mental illness are at high risk for multiple
comorbid medical illnesses, including cardiovascular disease and diabetes,
exacerbated by the known metabolic side effects of commonly used medications.
The development and testing of algorithms for antipsychotic treatment to
minimize medical consequences of mental health treatment could substantially
improve health of people with SMI and ultimately improve life expectancy.

Depression continues to confer high cost and burden of illness
across the US population. While treatment of depression has yielded
significant gains, more impact may be realized through prevention of depression
in individuals at risk due to persistent anxiety, subsyndromal depression,
family history, and critical periods of risk. The development and testing of
strategies to reduce incidence of depression in large populations could
dramatically improve health and reduce burden on care systems.

Pilot Projects

The Pilot Projects are designed
to test the feasibility of conducting additional trials to those already
accomplished within the MHRN. They should be designed to pilot test identification,
recruitment, and enrollment protocols for patients, clinicians and health care organizations, and
should be of two basic types:

(1) projects that demonstrate additional capability
for conducting a range of impactful trials not previously conducted on the
network (e.g. pharmacotherapy; clinical algorithms; large-scale health IT
trials) and

(2) resource improvement/methodological research projects,
which build new efficiencies in the conduct of high-impact effectiveness and
services research.

It is expected that these projects will result in studies
conducted below historic study costs by an order of magnitude. Both types of
projects should involve MHRN-affiliated as well as non-affiliated investigators
wherever possible.

MHRN-affiliated investigators are encouraged to plan for
their engagement in both types of projects. Non-MHRN-affiliated researchers may
be more inclined to engage in the second type of projects. These pilot
projects should be similar to traditional NIH exploratory/developmental (R21)
projects in terms of emphasis on exploration of new ideas, generating
preliminary data, testing the feasibility of a bigger study, etc. Projects of
this type are expected to serve as a main channel for research collaborations
between external investigators and MHRN experts.

A
successful MHRN will accomplish the following tasks within the
period of the award:

Extend the capacity of the network to conduct prospective trials
via the successful completion of multiple pilot studies of types of
interventions not yet studied across multiple network sites (e.g.
pharmacotherapy, large-scale delivery of IT interventions, clinical
algorithms).

Successfully complete a Signature Project of high impact on the
mental health of a large population.

Benchmark the costs of conducting a range of studies on the
network compared to historical norms, and progress toward network-involved
trials to be completed with costs at an order of magnitude below prior norms.

Expand tools to create efficiency in the conduct of effectiveness
and services research studies on the network.

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, NIH staff will assist,
guide, coordinate, or participate in project activities.

Application Types Allowed

Renewal

The OER
Glossary and the PHS 398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

NIMH intends to commit $2,000,000 in FY 2014 to fund one
award.

Award Budget

Application budgets are limited to $2,000,000 per year in
total costs for up to five years, and need to reflect actual needs of the
proposed project.

Award Project Period

The total project period may not exceed five years.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

As this FOA is a limited competition opportunity, only the
institutions that are the principal employers of the PD(s)/PI(s) of the current
Mental Health Research Network (MHRN) are eligible to apply to this FOA.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the PHS 398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

System for
Award Management (SAM)– must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the Sam.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Only one application per institution (normally identified by
having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally submitted
to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Address to Request
Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398
Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the PHS 398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All instructions in the PHS 398 Application Guide
must be followed, with the following additions:

Description: Using Page 2 of Form 398; provide a succinct but accurate description
(abstract) of the overall multi-project application addressing the major,
common theme of the program. Do not exceed the space provided.

Project/Performance
Sites: List the performance sites where the research will be
conducted.

The Network must include a sufficient number of
health care organizations such that total patient enrollment is stable (i.e.,
the majority of patients can be followed for a combined retrospective and
prospective period of five years) and is at least three million adults (ages 18
and over). Also, network-covered populations should approximate the
demographics of the general U.S. population, and must include diverse
populations with respect to gender, race/ethnicity and, to the extent that it
is practical, rural/urban populations and a range of geographic locations.

Senior/Key Personnel: List only the PD(s)/PI(s)
of the multi-project application.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide
must be followed.

Detailed Budget for Initial Budget
Period (Overall)

No detailed budget information should be provided in
the Overall component for the initial budget period. Budgets for the
Administrative core,

The PI(s)/PD(s) of the MHRN funded under this FOA are
expected to devote at least 3.6 person/months overall, based on a 12-month
calendar (equivalent to a total of 30% of his/her time and effort) to the
project.

Budget for Entire Proposed Period of
Support (Overall)

All instructions in the PHS 398 Application Guide
must be followed.

Do not use Form Page 4 of PHS Form 398.
Instead, using the suggested format presented below, prepare a Composite Budget
for All Proposed Years of Support. (Justification for budget elements should
not be presented here but in the individual budgets of the network
infrastructure and research projects.)

SAMPLE: Consolidated Direct Cost Budget for All Proposed
Years of Support. Add other Projects and Cores as appropriate to the FOA.

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Administrative Core

$550,000

$550,000

$550,000

$5505,000

$550,000

$2,750,000

Signature Project

$450,000

$450,000

$450,000

$450,000

$450,000

$2,250,000

Pilot Project A

$125,000

$125,000

$125,000

$0

$0

$375,000

Pilot Project B

$0

$125,000

$125,000

$125,000

$0

$375,000

Pilot Project C

$0

$0

$125,000

$125,000

$125,000

$375,000

Totals

$1,125,000

$1,250,000

$1,375,000

$1,250,000

$1,250000

$6,250,000

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide
must be followed.

Resources (Overall)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instruction:

The resources section should include descriptions of shared
resources across the Administrative Core, Signature Project and Pilot Projects.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Introduction
to Application: This section should provide details on progress
made in the first three years of the MHRN, including brief descriptions of (1)
infrastructure developed and (2) results from pilot investigations.

Specific
Aims: The overall, broad objectives of the MHRN, including a
description of what it intends to accomplish in this funding period, should be
described in this section..

Research
Strategy:

Background and Significance. Focusing on the network
as a whole, this section should address (i) the importance of the problem or
critical barrier to progress that the proposed network will address, (ii) how
past activities of the MHRN have contributed to a solution to the problem or
barriers to progress, (iii) how the structure of the MHRN and research studies
to be conducted will facilitate improvements in scientific knowledge, research
capacity, and/or clinical practice, and (iv) how the activities of the MHRN
will change the field if the proposed aims are achieved.

This section should also demonstrate a shared
commitment among all participating network members to working together on
proposed research studies. Applicants must show evidence of ability to
access and organize data collection from all participating network members and
to utilize an integrated system across all sites. Applicants should also
demonstrate linkage of electronic laboratory, pharmacy, outpatient, and
hospitalization data at many network sites. If these capabilities do not
currently reside within one or more of the network members, the applicant must
include details of plans to develop the necessary linkages and integration in
all network members. Applicants must demonstrate previous research
productivity using the data resources available to their network. Each
network member must have access to a resource unit that supports research data
management.

Innovation. This section should describe the new
directions that the MHRN will take in the next project period, and how the
overall program of research and structure will advance the field above and
beyond work already completed.

Approach. This section should describe the overall structure
of the MHRN, including a discussion of how the administrative core and
individual research projects (including the signature project and pilots) will collectively
accomplish the aims of the network.This section should show how the MHRN as a
whole will complement past or ongoing mental health research in the health care
organizations, particularly research that has used available data resources and
existing electronic data systems. This section should also briefly describe
the health care organizations, including their size, diversity and stability of
the patients, demographic composition of the patient population, and diversity
of their geographic service areas; the potential significance of the MHRN in
these organizations; and any relevant research conducted to date in these
organizations, including that which demonstrates improved efficiency over typical
research study execution.

Protection
for Human Subjects: This section should discuss the proposed
protections from research risk related to the overall network. For the
research infrastructure, applications should discuss efforts to ensure privacy and
confidentiality of all data, and ensure that proposed activities include
adequate attention to risk for all potential research subjects, including
patients, providers, and administrators. Specific descriptions of efforts to
increase efficiency in recruitment and enrollment of research participants
while maximizing necessary protections should be included in this section.
Specific protections from research risk related to the Administrative Core, Signature
project and pilot studies should be included within the relevant sections
below.

Resource
Sharing Plan:Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398
Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Administrative
Core

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions, as noted.

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Description: Using Page 2 of Form 398; provide a succinct but accurate description (abstract)
of the Administrative Core, including the structure of the core, briefly
explaining the roles of units and workgroups. Do not exceed the space
provided.

Project/Performance
Sites: List the performance sites that apply to the
Administrative Core.

Senior/Key
Personnel: List the PD/PI of the Administrative Core, leadership
of the units and workgroups, other key personnel, and other significant
contributors.

Table of Contents (Administrative
Core)

All instructions in the PHS 398 Application Guide must
be followed.

Detailed Budget for Initial Budget
Period (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional insructions:

Applications should include a budget for the overall
governance structure of the Administrative Core, along with a budget
justification.

Costs for organizing an annual meeting in Bethesda,
MD, should be included in the budget, including support for meeting attendance
by the PD/PI, the Project Leaders and Cores leaders, and other key personnel.

Budget for Entire Proposed Period of
Support (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instruction:

List the units and workgroups of the Administrative
Core with associated costs across all proposed years of support.

Biographical Sketch (Administrative
Core)

All instructions in the PHS 398 Application Guide
must be followed.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instruction:

The resources section should include descriptions of
facilities and resources at all participating network sites.

Research Plan (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Specific
Aims: Clearly state how the core will contribute to the overall
goals of the MHRN and outline interactions of the core with the Signature
Project and Pilot Projects.

Research
Strategy:

Governance and Operational Structure. This section
should provide an overview of the proposed Administrative Core of the MHRN, describing
the functional units (e.g., Organizational, Informatics, and Outreach and External
Collaboration), and any other committees/workgroups, and how these entities
would function to support and maintain the structure and research projects of
the MHRN.

Research Infrastructure. The infrastructure should be
described in detail, and organized by units to perform administrative, data
standardization and integration, and evaluation functions. The
application should have separate sections for each of the three required units,
and any additional units and workgroups to be included. These units should
support the signature project and pilot studies.

Organizational
Unit. This section should provide information on the structure and process of
the MHRN, including PD/PI, key investigators, Steering Committee, and the detailed
plans for the oversight of the units, workgroups, and research projects of the
MHRN. The narrative should address how communication and collaboration will be
established and maintained between the research projects and the administrative
units across participating MHRN health care organizations, participating
federal agencies (i.e., NIMH/NIH), and other research collaborators.
Appropriate structures to oversee quality control of the research (e.g.,
internal or external advisory committees) should be described in this section,
as well as procedures for evaluating the administrative units, overall MHRN
functioning, and progress of the individual research projects, as well as for
implementing recommendations resulting from such evaluations.

Informatics
Unit. This section should provide information on how the data infrastructure
and resources of the MHRN, including the VDW, will be managed and improved over
time. Unit functions should include plans for how the standardization of data
resources for mental health effectiveness research will be increased and the
role of the unit in the development, or application, of mental health
informatics resources and tools. The core resources should be designed to be
helpful to both network and non-network researchers in developing research applications
for extramural funding.

Outreach
and external Collaboration Unit. This section should provide information on
the structure and process of the MHRN's efforts to enhance 1) collaboration on
research studies with health care organizations within and outside MHRN, and
network and non-network researchers and organizations, and 2) dissemination of
research findings within the partnering health systems. The application should
also describe plans to encourage and create opportunities for research
collaboration with interested non-network researchers and organizations for the
use of MHRN study datasets. Detailed information on procedures for reviewing
and initiating new research and practice collaborations should be included in
this section

Additional
Units and Workgroups. This section should provide information on additional
administrative or thematic units and workgroups that will serve to advance the
mission of the MHRN, detailing the structure and process of each of these
units, defined purpose, and intended outcomes.

This section should also include information on the
planning of an annual in-person meeting of the MHRN steering group in Bethesda,
MD.

Protection
for Human Subjects: This section should discuss any procedures
within the Administrative Core to manage efforts around the protections from
research risk related to the MHRN research projects.

Each application should propose a Signature Project, as
described below, and at least three Pilot Projects that are aimed at extending
the current capacity of the network to conduct a range of effectiveness and
services research studies.

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions, as noted.

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Description: Provide a Description (abstract) of the research proposed in the individual
research project according to the instructions on Form Page 2 of PHS Form
398. In addition, the abstract should contain a brief description of how
the individual research project will contribute towards attainment of the
multi-project objectives.

Project/Performance
Sites: List the performance sites where the research will be
conducted.

Key
Personnel: List the Project Leader, followed by other key
project personnel, and then other significant contributors.

Table of Contents (Research Projects)

All instructions in the PHS 398 Application Guide
must be followed.

Detailed Budget for Initial Budget
Period (Research Projects)

All instructions in the PHS 398 Application Guide
must be followed for each research project (Signature and Pilot).

Budget for Entire Proposed Period of
Support (Research Projects)

All instructions in the PHS 398 Application Guide
must be followed for each research project (Signature and Pilot).

Biographical Sketch (Research Projects)

All instructions in the PHS 398 Application Guide
must be followed for each research project (Signature and Pilot).

Resources (Research Projects)

All instructions in the PHS 398 Application Guide
must be followed for each research project (Signature and Pilot), including
descriptions of facilities and resources at the sites involved within the
specific project. This may include non-MHRN research and clinical sites.

Research Plan (Research Projects)

All instructions in the PHS 398 Application Guide
must be followed for each research project (Signature and Pilot), with the
following additional instructions:

Specific
Aims: List, in priority order, the objectives and goals of the
proposed Research Project. This applies to both the Signature Project and all
Pilot Projects. Concisely and realistically describe the hypothesis or
hypotheses to be tested. In addition, state the individual research project's
relationship to the overall MHRN goals and if it relates to other projects or to
specific activities of the Administrative Core.

Research
Strategy:

Signature
Project: This
section should provide details about how the MHRN resources will be used to
complete a high impact Signature project, as detailed in Part 2, Section
1. The Signature Project should be consistent with the goals identified
earlier in this FOA. The narrative should provide information on: (1) Significance,
(2) Innovation, and (3) Approach, as detailed in the "Research Strategy"
section of the PHS 398 instructions. Applicants should explain how the proposed
Signature Project will demonstrate the network's capacity to perform an
efficient, large-scale trial at a significantly lower cost than historical
comparisons, in an area of high public health importance, as described above.

Pilot
Projects:

This section should provide details about how the MHRN
resources will be used to complete at least three pilot projects, each described
separately. The research should be consistent with the goals identified
earlier in this FOA. The narrative should provide information on: (1) Significance,
(2) Innovation, and (3) Approach, as detailed in the "Research Strategy"
section of the PHS 398 instructions. Applicants should demonstrate how the
pilot projects are synergistic and show the potential for the network to expand
its capacity to conduct a range of prospective trials. Applicants must provide
milestones and timelines for each research project.

Applications must be received on or before the due dates in Part I. Overview Information. If an
application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are
incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, note the following:

Peer review emphasizes a synthesis of three major aspects of
the U19 application: (1) review of the merit of the overall network (including
the organizational structure), (2) review of the Signature Project, and (3) review
of the additional pilot projects compared to a standard of quality in a
related, broad, scientific discipline. This synthesis will result in a
final review of the program as an integrated research effort designed to
improve the quality and efficiency of mental health effectiveness and services
research conducted in integrated health care systems.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the MHRN to exert a sustained, powerful influence on the research field(s) involved, in consideration
of the following review criteria and additional review criteria (as applicable
for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the MHRN address an important problem or a critical barrier to progress in the field? If the aims
of the MHRN are achieved, how will scientific knowledge, technical capability,
and/or clinical practice be improved? How will successful completion of the
aims change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field? What is the potential of the overall MHRN program to advance knowledge that will improve outcomes of patients
with mental disorders receiving care in integrated healthcare systems? Do the
proposed activities of the MHRN have a high likelihood of significantly
advancing mental health services and intervention research, above and beyond
prior accomplishments of the network? Do the proposed activities appear to
improve the efficiency of large-scale prospective studies to be conducted, at
significantly reduced costs as compared to historical norms?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the goals of the MHRN? If Early Stage Investigators
or New Investigators, or in the early stages of independent careers, do they
have appropriate experience and training? If established, have they
demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project? Do the qualifications of the PD/PI and other senior scientists to lead the MHRN
scientifically and coordinate all activities include demonstrated ability to
provide effective scientific and administrative leadership, particularly in the
engagement of researchers from outside the MHRN and health system participants
within and outside the MHRN? In addition, do the qualifications of the PD/PI
and other key personnel include adequate expertise in the areas in which the
MHRN is designed to expand (e.g. health IT, pharmacology trials, methods)?

Innovation

Does the application challenge and seek to shift current
research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed? To what degree does the overall program apply novel concepts and innovative approaches to
the efficient conduct of pragmatic mental health effectiveness and services
research? Does the application describe innovative and efficient mechanisms
for identifying, recruiting, enrolling, and monitoring subjects within
effective research studies and for conducting large-scale prospective trials?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the MHRN? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the MHRN involves clinical research, are the plans for 1) protection of human
subjects from research risks, and 2) inclusion of minorities and members of
both sexes/genders, as well as the inclusion of children, justified in terms of
the scientific goals and research strategy proposed? Are the administrative plans for the management of the MHRN appropriate, including plans to resolve
conflicts? Does the MHRN effectively detail processes through which decisions
about future MHRN directions/priorities will be taken?

Environment

Will the scientific environment in which the work will
be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements? Is there clear evidence of the support and collaboration of the
health systems within which the MHRN sites exist? Is there an appropriate
environment and plan for the engagement of external institutions and
investigators in collaboration with the MHRN?

Review Criteria Signature Project

Overall Impact - Signature Project

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood (1) for the Signature Project to have
ultimate impact on the clinical practice and the health of the public, as well
as to exert a sustained, powerful influence on the research field, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Reviewers will consider each of the five review criteria
below for the Signature Project, in the determination of scientific and
technical merit, and give separate scores for each. Questions listed
should be answered for the proposed Signature Project.

Significance

Does the Signature Project address important problems
related to mental health effectiveness or services research? If the aims of the
research project is achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of this study on the concepts,
methods, technologies, treatments, services, or preventive interventions that
drive this field? Does the Signature Project address a high-impact
research topic, with the possibility of dramatically improving outcomes for
people with mental disorders?

Investigators

Are the investigators appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the project leader and other researchers? Does the
investigative team bring complementary and integrated expertise to the
project? Does the project involve sufficient network investigators to
demonstrate feasibility of conducting efficient multi-site investigations? Does
the research project include investigators from within the MHRN and external
investigators as part of the study team?

Innovation

Is the project original and innovative for the MHRN?
For example: Does the project challenge existing paradigms or clinical
practice; address an innovative hypothesis or critical barrier to progress in
conducting large-scale effectiveness research? Does the project develop or
employ novel concepts, approaches or methodologies, tools, or technologies for
this area? Do the emerging research issues represent necessary advances
for the fields of mental health services and effectiveness research, above and
beyond the prior work of the network? Does the Signature Project break new
ground in the efficient conduct of large-scale pragmatic trials?

Approach

Are the conceptual or clinical frameworks, designs,
methods, and analyses adequately developed, well-integrated, and appropriate to
the aims of the project? Does the applicant acknowledge potential problem areas
and consider alternative tactics? Does the project demonstrate ability to
efficiently identify, recruit, enroll, and track research subjects through
common protocols across multiple network sites? Does the research design show
optimal use of network research infrastructure, resulting in higher efficiency
in the conduct of research projects to historical norms?

If the project(s) involves clinical research, are the
plans for 1) protection of human subjects from research risks, and 2) inclusion
of minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed?

Environment

Does the scientific environment in which the work
will be done contribute to the probability of success? Does the proposed
experiment benefit from unique features of the scientific environment, or
subject populations, or employ useful collaborative arrangements? Is there
evidence of institutional support among the health care delivery systems?
Does the environment include sufficient network membership to
demonstrate ability to conduct the study across multiple geographical and
organizational settings?

NOTE: Synergy and thematic relatedness between the
projects and organizational structure, and their significance for the program
as a whole, are not discussed when rating the Signature Project (as well as the
set of pilot projects). These characteristics are discussed and rated under the
Impact score review criterion when evaluating the Overall MHRN.

Review Criteria - Pilot Projects

Reviewers should consider the set of pilot projects
collectively when assessing their merit and give a single score to reflect this
assessment. Reviewers should consider the following questions in determining the
overall scientific and technical merit of the pilot projects:

Do the set of pilot projects address important
problems related to mental health effectiveness or services research? If the
aims of the pilot projects are achieved, how will scientific knowledge or
clinical practice be advanced? Are the pilot projects demontrate expansion of
the MHRN's research capacity to conduct new types of studies than those
previously carried out across the network? Do the projects involve
investigators outside of the MHRN, with complementary expertise to the current
investigators within the network? Do the projects use and extend the capacity
of the network to efficiently identify, recruit, enroll and track research
subjects through common protocols across multiple network sites?

Additional Review Criteria - Overall

As applicable for the MHRN proposed, reviewers will evaluate the following additional items while determining
scientific and technical merit, and in providing an overall impact score, but
will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities
and members of both genders, as well as the inclusion of children. For
additional information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the MHRN proposed, reviewers will consider
each of the following items, but will not give scores for these items, and
should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety,
biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the NIMH, in accordance with NIH
peer review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted
response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all
other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of
review by the National Advisory Mental Health Council. The following will be
considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable
when State and local Governments are eligible to apply), and other HHS, PHS,
and NIH grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.

The
PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) will have the primary responsibility for the
MHRN effort as a whole, including research design and the actual performance of
the MHRN effort, and preparation of publications.

The PD(s)/PI(s) will attend all MHRN Steering Committee
meetings, will annually document progress in written reports to the NIMH Program
Director, and will provide periodic supplementary reports upon request.

To accommodate the changing environment resulting from
improved technologies, the PD(s)/PI(s) is expected to make any necessary
adjustments in the overall research strategies during the course of the project
period. Although joint research projects are strongly encouraged under this FOA,
research projects within an application are also allowed to be conducted under
the supervision of site-specific Project Leaders at individual MHRN member
organizations otherwise contributing to meeting the goals and objectives of
this FOA. Project Leaders of such single member organization studies within an
application will have equivalent status with all other PD(s)/PI(s) in regard to
participation on the MHRN Steering Committee and other MHRN committees.

The awardee will retain custody of and have primary rights
to the data developed under this award, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies. The awardee and NIMH will
jointly develop appropriate confidentiality procedures for data collection,
processing, storage and analysis to ensure the confidentiality of data on
individual health care organization patients, health care providers and
institutions involved in MHRN research projects. No identifying information of
individual patients or providers should be available through aggregated MHRN
research databases. Encrypted study identification numbers will be used
for all aggregated MHRN studies. The NIMH expects that limited access data will
be released under this study. Limited access data refers to study data,
with certain deletions and recoding that are released to requesting
institutions and investigators for specific purposes and with certain restrictions
and conditions.

The PD(s)/PI(s) will be responsible for the timely
submission for publication of manuscripts (co)authored by members of the grant
and supported in part or in total under this Agreement. All publications
and presentation abstracts resulting from work done will be submitted to the
Program Officer at least one week prior to journal submission for review, and
within two weeks of acceptance for publication so that an up-to-date summary of
the cooperative program accomplishments can be maintained and NIMH press
releases can be prepared, if applicable. Publications or oral
presentations of work performed under this Agreement are the responsibility of
the PD(s)/PI(s) and appropriate Project Leaders and require acknowledgement of
NIMH support. Timely publication of major findings is encouraged

NIMH
staff have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below:

NIH/NIMH will assign one staff member to serve as the Project
Scientist. The Project Scientist will have substantial programmatic involvement
that is above and beyond the normal stewardship role in awards, as described
below:

Substantial involvement in coordinating the activities of the
awardee with the non-MHRN researchers, as necessary.

Participation in the Steering Committee and subcommittees

Serving as a resource with respect to other ongoing NIMH/NIH
activities that may be relevant to this effort and providing expert advice to
the awardee on specific scientific and/or analytic issues.

Assisting, with the agreement of the PD/PI, in the design,
development, and coordination of the MHRN, its cores, and its studies.

Reviewing study design and protocols, data abstraction and survey
instruments, and analysis plans to ensure that they are within the scope of
this effort and consistent with the results of peer review.

In addition to the Project Scientist, an NIMH Program
Officer will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the award notice.

The NIMH reserves the right to terminate or curtail the MHRN
(or an individual component of the award) in the event of inadequate progress,
data reporting, insufficient use of this resource, or safety issues.

The NIMH Program Officer will interact with the PD(s)/PI(s)
on a regular basis to monitor progress. Monitoring may include: regular
communication with the PI and his/her staff, periodic site visits for
discussion with the awardee research team, observation of field data collection
and management techniques, fiscal reviews, and other relevant stewardship
matters.

The NIMH Program Officer may also identify additional
extramural staff from NIMH and other participating organizations that have
appropriate experience and expertise to collaborate with MHRN in the
development of research concepts, review of study designs and methods,
participation in study analyses, and review of scientific reports and
articles. These additional staff may serve on various MHRN committees.

Areas
of Joint Responsibility include:

During the course of the award period, the awardee will be
invited to meet with the NIMH, other PDs/PIs, and/or other uninvolved experts
in Bethesda, MD, to review scientific progress.

The MHRN Steering Committee will be the main oversight body
for this cooperative agreement. The Steering Committee will coordinate the
overall governance of the MHRN and establish and administer specific MHRN-wide
policies. Membership of the Steering Committee will consist of the MHRN PD/PI,
Project Leaders from each MHRN member organization, Project Leaders for each
MHRN research project detailed in Research Plan Section E., and the Project
Scientist from NIMH. The chair of the Steering Committee will be selected by
the Steering Committee members in consultation with the NIMH. Each full member
will have one vote.

The Steering Committee will periodically review the research
agenda and specific research projects, review the evaluation of the overall
operations of the MHRN, determine directions for future development and
improvement, and share experiences in implementing the MHRN activities. It is
expected that decisions made or actions taken by the Steering Committee will be
by consensus, or majority vote when needed, and all network organizations will
be expected to implement them. Meetings of the Steering Committee will
frequently be held by teleconference calls with in-person meetings usually held
twice each year (see Section IV.6). Financial support for these meetings should
be included in the MHRN application budget.

Dispute Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to dispute resolution. A Dispute Resolution Panel
composed of three members will be convened. The three members will be: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required
to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR)
annually and financial statements as required in the NIH Grants
Policy Statement.

A final progress report, invention statement, and the
expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.